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FDA 510(k)

BoneMRI v1.4

K-Number: K221762 · 2022-11-16

ApplicantMrlguidance B.V.
Decision Date2022-11-16
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BoneMRI v1.4 is the device name listed in this FDA 510(k) record. The listed applicant is Mrlguidance B.V.. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K221762. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BoneMRI v1.4?

BoneMRI v1.4 is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Mrlguidance B.V.. The 510(k) number is K221762.

When did BoneMRI v1.4 receive FDA 510(k) clearance?

BoneMRI v1.4 received FDA 510(k) clearance on 2022-11-16, under 510(k) number K221762.

Who is the listed applicant for BoneMRI v1.4?

The FDA 510(k) record lists Mrlguidance B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BoneMRI v1.4?

The FDA product code for BoneMRI v1.4 is QIH.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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